Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

Test animals

Species:
rat
Strain:
other: Hanlbm: WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation:Males:8 -10 weeks
Females: 8 -10 weeks
- Weight at study initiation:Males: 239.7 - 249.7 g
Females: 175.5-188.3 g
- Housing:Groups of three in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet (e.g. ad libitum):Pelleted standard Kliba 3433, batch no. 03/00, rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum (except during treatment, see section 5.6). Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum):Community tap water from Füllinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period:One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-23.5
- Humidity (%):39-61
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12- hour artificial fluorescent light, 12-hour dark cycle.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Polyethyleneglycol PEG 300
Details on oral exposure:
VEHICLE
- Concentration in vehicle:10 ml

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 males
3 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,mortality
Statistics:
No statistical analysis was used.

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
MORTALITY:
No deaths occurred during the test.
CLINICAL SIGNS:
No clinical signs of toxicity observed.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
Effects on organs:
No treatment-related macroscopic findings were observed.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of FAT 60'253/A after single oral administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight
Executive summary:

Two groups, each using three male or three female Hanlbm: WIST (SPF) rats, were treated with FAT 60'253/A at 2000 mg/kg by oral gavage. The test item was suspended in vehicle polyethylene glycol 300 (PEG 300) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1 and then twice daily on test days 2-15.

Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study.

No clinical signs were observed during the observation period.

The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were observed at necropsy.

The median lethal dose of FAT 60'253/A after single oral administration to rats of both sexes, observed over a period of 14 days is:

LD50 (rat): greater than 2000 mg/kg body weight